Efferalgan

Patient Information Leaflet

Caution! Keep this leaflet! Information on the immediate packaging in a foreign language
Efferalgan (Efferalgan 80 mg)
80 mg, suppositories
Paracetamolum
Efferalgan and Efferalgan 80 mg are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of Contents

1. What Efferalgan is and what it is used for
2. Important information before using Efferalgan
3. How to use Efferalgan
4. Possible side effects
5. How to store Efferalgan
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan is a medicine with analgesic and antipyretic properties. It reduces elevated body temperature occurring during illness, but does not lower normal body temperature.
Indications:

• fever,
• symptomatic treatment of influenza-like conditions and colds,
• pain of various origins.

2. Important information before using Efferalgan

When not to use Efferalgan

• if the patient is allergic to paracetamol, propacetamol hydrochloride (a paracetamol precursor), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver failure or active, untreated liver disease,
• if the patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may lead to haemolytic anaemia,
• if the patient is being treated with MAO inhibitors (medicines used, among others, in depression) or within 14 days after stopping such treatment,
• in patients who recently had inflammation of the anus, rectum, or bleeding from the anus.

This medicine contains soya oil. Do not use if peanut or soya allergy has been diagnosed.

Warnings and precautions

Before starting to use Efferalgan, discuss this with your doctor, pharmacist, or nurse.

Efferalgan contains paracetamol. To avoid overdose, check whether other medicines (including those prescribed and those available without prescription) taken by the patient contain paracetamol. Overdose may lead to severe liver damage and death.

Efferalgan may be used in children under 2 years of age only on a doctor's advice. If a child is receiving a paracetamol dose of 60 mg/kg body weight/day, the use of other antipyretic medicines may be considered only if the effect is insufficient.

When using suppositories, there is a risk of local irritation, the frequency and severity of which increase with the duration of treatment, frequency of use, and dose of the medicine.

Do not use doses higher than recommended. Using paracetamol doses higher than recommended carries a risk of severe liver damage.

Paracetamol may cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal.

Inform your doctor if skin reactions occur.

Consult your doctor before using Efferalgan if the patient has any of the following conditions:

• liver dysfunction, including Gilbert's syndrome (familial hyperbilirubinemia),
• severe renal failure,
• alcohol-related disease,
• eating disorders: anorexia, bulimia, or cachexia,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration,
• reduced circulating blood volume.

Prolonged (over 3 months) use of painkillers in patients with chronic headache, taken on alternate days or more frequently, may lead to the development or worsening of headache. Medication-overuse headache (MOH) should not be treated by increasing the dose. In such cases, in consultation with a doctor, painkillers should be discontinued.

Efferalgan and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Concurrent use of Efferalgan may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Efferalgan taken simultaneously:

MAO inhibitors (a group of medicines used in the treatment of depression) – do not use simultaneously with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of excitation and high fever.

Medicines containing salicylamide (an analgesic also used in fever) – concurrent use may prolong paracetamol elimination time.

Enzyme-inducing substances: caution is required when using paracetamol together with medicines that increase hepatic metabolism, such as antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (a medicine used in tuberculosis), and isoniazid (a medicine used in tuberculosis). This may lead to liver damage, even when recommended paracetamol doses are used (see section "Use of a higher than recommended dose of Efferalgan" in section 3).

Non-steroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney function disorders.

Oral anticoagulants – concurrent use of paracetamol with coumarin anticoagulants, including warfarin, may lead to slight changes in INR values. In such cases, the doctor may increase the frequency of INR monitoring during and for one week after discontinuation of paracetamol.

Phenytoin (a medicine used in epilepsy) – concurrent use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or long-term paracetamol doses. These patients should be monitored by a doctor for signs of hepatotoxicity.

Probenecid (a medicine used in gout) – reduces paracetamol elimination. When using this medicine together with probenecid, the doctor should consider reducing the paracetamol dose.

Flucloxacillin – exercise caution when using flucloxacillin simultaneously with paracetamol due to an increased risk of developing a blood and body fluid disorder (metabolic acidosis with a high anion gap), especially in patients with risk factors for glutathione deficiency such as severe renal dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with a high anion gap is a serious condition requiring urgent treatment.

Inform your doctor that you are using this medicine if your doctor orders tests for uric acid or blood glucose.

Use of Efferalgan with alcohol

Do not drink alcohol due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

This medicine is intended for children (see section 3).

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Other medicines containing paracetamol as the active substance have been authorized for adult use.

Paracetamol may be given to pregnant women if necessary. Use the lowest effective dose to relieve pain or reduce fever, and take the medicine for the shortest possible time.

If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult a doctor.

This medicine may be used during breastfeeding only with a doctor's approval and in individual cases.

There are insufficient available data to determine whether paracetamol affects fertility.

Driving and operating machinery

The medicine does not affect psychomotor performance. There are no contraindications to driving or operating machinery.

3. How to use Efferalgan

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
In children, dosing should be based on body weight; therefore, select the Efferalgan preparation of appropriate strength. The approximate age corresponding to a given body weight is provided only as a guideline.
The recommended single dose of paracetamol in children is approximately 15 mg/kg body weight (bw). If necessary, it may be administered up to 4 times daily, no more frequently than every 6 hours. The recommended maximum daily dose of paracetamol is approximately 60 mg/kg bw.
Efferalgan 80 mg suppositories are intended for infants and children with body weight from 5 to 10 kg (approximately 2 to 24 months of age) and should be used only on medical advice.
The recommended single dose is 1 suppository (80 mg paracetamol). If necessary, the dose may be repeated, no more frequently than every 6 hours. Do not use more than 4 suppositories per day (maximum daily dose of paracetamol is 320 mg).

Patients with renal function impairment
In patients with severe renal impairment, the minimum interval between doses should follow this scheme:
Creatinine clearance Interval between doses
CrCl ≥ 10 ml/min 6 hours
CrCl < 10 ml/min 8 hours

Patients with hepatic function impairment
In patients with impaired liver function, the dose should be reduced or the dosing intervals extended. In the following situations, the maximum daily dose should not exceed 60 mg/kg bw/day (and should not exceed 2 g/day):

• adults with body weight below 50 kg,
• chronic or compensated active liver disease, mild to moderate liver insufficiency,
• Gilbert's syndrome (familial non-haemolytic hyperbilirubinaemia),
• chronic alcohol-related disease,
• chronic malnutrition (low hepatic glutathione reserves),
• dehydration.

Method of administration
Rectal administration. Suppositories are not recommended in children with diarrhoea.

Frequency of use
Due to the potential for local irritant effects, suppositories should not be used more than 4 times daily.
Regular administration of the medicine helps prevent periodic exacerbations of pain or fever.
In children, maintain equal 6-hour intervals between doses both during the day and at night.

Duration of treatment
The duration of suppository use should be as short as possible. Do not use this medicine for longer than 3 days without consulting a doctor.

Use of a higher than recommended dose of Efferalgan
If a dose higher than recommended is used, contact a doctor immediately, even if no symptoms are present, because life-threatening liver damage may occur.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, patients with alcohol-related disease, liver diseases, and patients taking drugs that induce liver enzymes, as these patients have an increased risk of liver damage.
Overdose may cause symptoms appearing within several to several dozen hours, such as: nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, despite the onset of liver damage, which may manifest as abdominal discomfort, recurrence of nausea, and jaundice.
Rare cases of acute pancreatitis have been observed.

Missed dose of Efferalgan
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of the adverse effects listed below is unknown – frequency cannot be estimated from the available data.
Unknown: increased liver aminotransferase activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of deep skin layers and subcutaneous tissue), diarrhoea, abdominal pain; thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils – a type of white blood cell); skin erythema, rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome.
*Very rare cases of hypersensitivity reactions requiring discontinuation of treatment (dyspnoea, bronchospasm, excessive sweating) have been reported.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Efferalgan

Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Efferalgan contains
The active substance is paracetamol. Each suppository contains 80 mg of paracetamol.
The other ingredients are: hard fat with additives, including lecithin derived from soybean oil.

What Efferalgan looks like and contents of the pack
Suppository.
Pack: 2 PVC/PE blisters in a cardboard box, each containing 5 suppositories.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, country of export:
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer:
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen, France
UPSA SAS
979, avenue des Pyrénées
47520 Le Passage, France

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in Bulgaria, country of export: 20020147
Parallel import authorisation number: 265/24